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Macsen Labs' Methylene Blue Synthesis Process receives Indian patent

Our Bureau, Bengaluru
Wednesday, December 8, 2021, 15:15 Hrs  [IST]

Udaipur-based Macsen Labs group’s Methylene Blue Synthesis Process treatment has been granted a patent from Indian patent office.

“Methylene Blue being such an old compound having a history of more than a hundred years is hardly available in required pharmaceutical grade and purity. Even in developed countries like the United States, there is only a single source of this life-saving medicine. It is really difficult to synthesize methylene blue in high purity because of the degradants formed during the oxidation process,” stated Achal Agrawal, CEO of Macsen Labs, and inventor of the patented process.

Looking at a large number of upcoming pharmaceutical applications of this compound, the new short process for yielding a high purity compound will be really beneficial for our industry, he added.

The patent is granted for the research in the field of chemistry is titled Novel Improved Method for Synthesis of Diaminophenothiazine Compounds. The patent concerns a novel process for synthesizing the compound Methylthioninium Chloride or Methylene Blue.

Methylene Blue is the first phenothiazine compound that was developed more than 140 years ago. It has a plethora of medicinal applications that have been under research since. The compound is already approved for treating a blood disorder called methemoglobinemia. Methylene Blue is currently under clinical trial for its experimental use in the treatment of Alzheimer’s disease. In 2008, a Phase II clinical trial concluded that a purified form of methylene blue slowed cognitive decline in people with mild to moderate Alzheimer's disease. Antimalarial use of the drug has recently been revived. It is also being studied as a photosensitizer for non-invasive photodynamic therapy of cancers.

The inventive process which has been patented yields a high purity compound in minimal steps and has eliminated lengthy purification procedures. Also, the process employs water-based chemistry that excludes the use of harmful chemical solvents, thus further eliminating the probability of occurrence of known or unknown impurities. The methylene blue compound that is obtained from Agrawal’s inventive process is of 99% purity and meets the Global Pharmacopoeia quality requirements established by compendiums such as United States Pharmacopoeia and European Pharmacopoeia (Ph. Eur.).

During the second wave of Covid-19, Macsen group also applied for emergency use of this drug with the CDSCO, but the emergency use was not granted without conducting clinical trials. Methylene Blue is not yet approved for any other disease apart from Methemoglobinemia, and it is a prescription drug that should not be consumed without advice from a medical professional.

 




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